CORONA Germany- Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany (CORONA Germany)

• ClinicalTrials.gov Identifier: NCT04659187
• Recruitment Status: Unknown
• First Posted: December 9, 2020
• Last Update Posted: December 17, 2020
• Sponsor: Asklepios proresearch
• Collaborator: Asklepios Kliniken GmbH & Co. KGaA
• Information provided by (Responsible Party): Asklepios proresearch

Study Description

Brief Summary:

This is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in Germany, all part of a German hospital network. All hospitalized patients tested positive for SARS-CoV-2 will be included.

Condition or disease
COVID-19

Detailed Description:

CORONA Germany is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in Germany, all part of a German hospital network. From January 1st till November 17th, 2020, all hospitalized patients tested positive for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) will be included. Demographical data and outcomes will be assessed in the entire study cohort. In a subgroup, consisting of 7 hospitals, further detailed data (e.g. baseline characteristics, laboratory values, medication, clinical events) will be assessed. Additionally, there will be subgroups of patients with cardiovascular events and prior or preexisting oncological diseases. There are two primary endpoints: 1. Combination of all-cause death and/or need for mechanical ventilation and/or allocation to intensive care unit (ICU). 2. Occurrence of a clinical manifest cardiovascular events. The aim of the study is the development of a prediction model for the primary endpoints, whereas the secondary endpoint is a comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave. All endpoints will be verified by an Endpoint Review Committee. A Steering Committee, consisting of representatives of the 45 hospitals, the trial statistician and members of the scientific department, takes responsibility of the study design and results.

Study Design

• Study Type: Observational
• Estimated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: "CORONA Germany" - Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany
• Actual Study Start Date: March 26, 2020
• Estimated Primary Completion Date: May 30, 2021
• Estimated Study Completion Date: July 1, 2021

Groups and Cohorts

Group/Cohort
All hospitalized COVID-19 patients; All consecutive hospitalized patients, tested positive for SARS-CoV-2 at 45 Asklepios hospitals in Germany
Subgroup: Detailed cohort of 7 hospitals; Cohort of 7 hospitals with detailed data set
Subgroup with cardiovascular events; Definition: Patients hospitalized to COVID-19, who developed a cardiovascular event, defined as (1) cardiopulmonary resuscitation in cardiac arrest, (2) cardiogenic shock, (3) acute coronary artery syndrome, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), (4) acute myocarditis, (5) denovo cardiac arrhythmia, (6) arterial or venous thrombosis, (7) pulmonary artery embolism, (8) worsening of prior or new onset heart failure, (9) ischemic stroke
Subgroup with oncological patients; Definition: Patients hospitalized to COVID-19 with prior or preexisting oncological disease
Subgroup with critical ill COVID-19 patients; Definition: Patients hospitalized to COVID-19 with intensive care treatment

Outcome Measures

Primary Outcome Measures :

1. Composite of death and/or need for mechanical ventilation and/or admission to ICU [ Time Frame: 9 months ]
   Composite of death and/or need for mechanical ventilation and/or admission to ICU in patients hospitalized to COVID 19
2. Occurrence of a clinical manifest cardiovascular event [ Time Frame: 9 months ]
   Occurrence of a clinical manifest cardiovascular Event, defined as (1) cardiopulmonary resuscitation in cardiac arrest, (2) cardiogenic shock, (3) acute coronary artery syndrome, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), (4) acute myocarditis, (5) denovo cardiac arrhythmia, (6) arterial or venous thrombosis, (7) pulmonary artery embolism, (8) worsening of prior or new onset heart failure, (9) ischemic stroke

Secondary Outcome Measures :

1. Overall mortality and mortality rate [ Time Frame: 9 months ]
   Comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave
2. Risk stratification score to predict the primary endpoints [ Time Frame: 9 months ]
   Risk stratification score to predict the primary endpoint in hospitalized COVID 19 patients in the subgroup of seven hospitals

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

all consecutive hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test)

Criteria

Inclusion Criteria:

• hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test)

Exclusion Criteria:

• Patients with negative SARS CoV-2 testing

Contacts and Locations

Contacts

Contact: Nele Gessler, MD; +49-401818 85 30 69; n.gessler@asklepios.com

Contact: Melanie Gunawardene, MD; +40-401818855412; m.gunawardene@asklepios.com

Locations

Germany

Asklepios Fachkliniken München-Gauting; Recruiting

Gauting, Bavaria, Germany, 82131

Principal Investigator: Jürgen Behr, Prof. MD

Principal Investigator: Lorenz Nowak, MD

Asklepios Klinik St. Georg; Recruiting

Hamburg, Germany, 20099

Principal Investigator: Ulrich-Frank Pape, MD

Principal Investigator: Bertholt Bein, Prof. MD

Principal Investigator: Stephan Willems, Prof. MD

Asklepios Klinik Wandsbek; Recruiting

Hamburg, Germany, 22043

Principal Investigator: Thomas Hölting, MD

Principal Investigator: Martin Bergmann, Prof. MD

Asklepios Klinik Barmbek; Recruiting

Hamburg, Germany, 22291

Principal Investigator: Axel Stang, Prof. MD

Principal Investigator: Sebastian Wirtz, MD

Asklepios Kliniken GmbH & Co. KGaA; Recruiting

Hamburg, Germany, 22307

Contact: Nele Gessler, MD

Principal Investigator: Christoph U Herborn, Prof. MD

Principal Investigator: Christian Glöckner, MD

Asklepios Klinik Nord; Recruiting

Hamburg, Germany, 22417

Principal Investigator: Klaus Herrlinger, Prof. MD

Principal Investigator: Tino Schnitgerhans, MD

Asklepios Westklinikum Hamburg; Recruiting

Hamburg, Germany, 22559

Principal Investigator: Rüdiger Schreiber, MD

Asklepios Klinik Altona; Recruiting

Hamburg, Germany, 22763

Principal Investigator: Dirk Arnold, Prof. MD

Principal Investigator: Hans-Peter Hauber, MD

Sponsors and Collaborators

Asklepios proresearch

Asklepios Kliniken GmbH & Co. KGaA

Investigators

• Principal Investigator: Christoph U Herborn, Prof. MD; Asklepios Kliniken GmbH & Co. KGaA

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gessler N, Gunawardene MA, Wohlmuth P, Arnold D, Behr J, Gloeckner C, Herrlinger K, Hoelting T, Pape UF, Schreiber R, Stang A, Wesseler C, Willems S, Arms C, Herborn CU. Clinical outcome, risk assessment, and seasonal variation in hospitalized COVID-19 patients-Results from the CORONA Germany study. PLoS One. 2021 Jun 17;16(6):e0252867. doi: 10.1371/journal.pone.0252867. eCollection 2021.

• Responsible Party: Asklepios proresearch
• ClinicalTrials.gov Identifier: NCT04659187
• Other Study ID Numbers: #3871
• First Posted: December 9, 2020
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual patient data will be collected anonymously. Sharing is not planned.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asklepios proresearch:

COVID-19; Corona; Risk factor; SARS-CoV-2

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases